SEEN BUT NOT HEARD? CHILDREN IN CLINICAL TRIALS
Although a body of law relating to medical treatment of children exists, the law is relatively undeveloped regarding clinical research. In this article, I consider the implications of the Medicines for Human Use (Clinical Trials) Regulations 2004. I argue that young people's right to self-deter...
Gespeichert in:
Veröffentlicht in: | Medical law review 2010, Vol.18 (1), p.1-27 |
---|---|
1. Verfasser: | |
Format: | Artikel |
Sprache: | eng |
Schlagworte: | |
Online-Zugang: | Volltext |
Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
container_end_page | 27 |
---|---|
container_issue | 1 |
container_start_page | 1 |
container_title | Medical law review |
container_volume | 18 |
creator | Cave, Emma |
description | Although a body of law relating to medical treatment of children exists, the law is relatively undeveloped regarding clinical research. In this article, I consider the implications of the Medicines for Human Use (Clinical Trials) Regulations 2004. I argue that young people's right to self-determination may not be adequately protected. In addition, I explore the implications of a 'direct positive benefit test', which may prove unduly restrictive of some types of paediatric research. |
doi_str_mv | 10.1093/medlaw/fwp024 |
format | Article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_miscellaneous_733146707</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><informt_id>10.3316/agispt.20230921095679</informt_id><oup_id>10.1093/medlaw/fwp024</oup_id><sourcerecordid>733146707</sourcerecordid><originalsourceid>FETCH-LOGICAL-c525t-63f0fa402182d473b289e521ae4870493b0985a0a051fa208eb73adce10d35f63</originalsourceid><addsrcrecordid>eNqFkL1PwzAQxS0EgvIxsqJssISe7TiOJ1TSQiKFgkqREIvlJg4EWhLsVIX_HpcUVqaT7n56791D6BjDOQZB-wtdzNWqX64aIMEW6uEgDHzKBWyjHoiQ-8ADsof2rX0FgJBGeBftEcBECMF6qH8_Go29y4epN76desloMBleeHGSZsOJ26djL87ScRoPMm86SQfZ_SHaKdXc6qPNPEAPV6NpnPjZ7fUa83NGWOuHtIRSBUBwRIqA0xmJhGYEKx1EHAJBZyAipkABw6UiEOkZp6rINYaCsjKkB-i0021M_bHUtpWLyuZ6Plfvul5aySl1n3LgjvQ7Mje1tUaXsjHVQpkviUGuK5JdRbKryPEnG-XlzF3-6N9OHJB0gFlUrVTPlW1aabUy-Yus3sv6Z12bZ1nU1drDJQl_MQKEgiDOloVcOKmzTqpeNv_G2rxR2VZ__sHKvMmQU85k8vgkb9hVchnfxfKJfgNkZJLZ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>733146707</pqid></control><display><type>article</type><title>SEEN BUT NOT HEARD? CHILDREN IN CLINICAL TRIALS</title><source>MEDLINE</source><source>Oxford University Press Journals All Titles (1996-Current)</source><source>Alma/SFX Local Collection</source><creator>Cave, Emma</creator><creatorcontrib>Cave, Emma</creatorcontrib><description>Although a body of law relating to medical treatment of children exists, the law is relatively undeveloped regarding clinical research. In this article, I consider the implications of the Medicines for Human Use (Clinical Trials) Regulations 2004. I argue that young people's right to self-determination may not be adequately protected. In addition, I explore the implications of a 'direct positive benefit test', which may prove unduly restrictive of some types of paediatric research.</description><identifier>ISSN: 0967-0742</identifier><identifier>EISSN: 1464-3790</identifier><identifier>DOI: 10.1093/medlaw/fwp024</identifier><identifier>PMID: 20129995</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Advisory Committees ; Child, Preschool ; Children ; Clinical trials ; Clinical Trials, Phase I as Topic - legislation & jurisprudence ; Diseases ; Guidelines as Topic ; Humans ; Informed consent (Medical law) ; Informed Consent - legislation & jurisprudence ; Internationality ; Law and legislation ; Patient Rights - legislation & jurisprudence ; Pediatrics ; Risk Assessment ; Treatment ; United Kingdom</subject><ispartof>Medical law review, 2010, Vol.18 (1), p.1-27</ispartof><rights>The Author [2010]. Published by Oxford University Press; all rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org 2010</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c525t-63f0fa402182d473b289e521ae4870493b0985a0a051fa208eb73adce10d35f63</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,1578,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20129995$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Cave, Emma</creatorcontrib><title>SEEN BUT NOT HEARD? CHILDREN IN CLINICAL TRIALS</title><title>Medical law review</title><addtitle>Med Law Rev</addtitle><description>Although a body of law relating to medical treatment of children exists, the law is relatively undeveloped regarding clinical research. In this article, I consider the implications of the Medicines for Human Use (Clinical Trials) Regulations 2004. I argue that young people's right to self-determination may not be adequately protected. In addition, I explore the implications of a 'direct positive benefit test', which may prove unduly restrictive of some types of paediatric research.</description><subject>Advisory Committees</subject><subject>Child, Preschool</subject><subject>Children</subject><subject>Clinical trials</subject><subject>Clinical Trials, Phase I as Topic - legislation & jurisprudence</subject><subject>Diseases</subject><subject>Guidelines as Topic</subject><subject>Humans</subject><subject>Informed consent (Medical law)</subject><subject>Informed Consent - legislation & jurisprudence</subject><subject>Internationality</subject><subject>Law and legislation</subject><subject>Patient Rights - legislation & jurisprudence</subject><subject>Pediatrics</subject><subject>Risk Assessment</subject><subject>Treatment</subject><subject>United Kingdom</subject><issn>0967-0742</issn><issn>1464-3790</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkL1PwzAQxS0EgvIxsqJssISe7TiOJ1TSQiKFgkqREIvlJg4EWhLsVIX_HpcUVqaT7n56791D6BjDOQZB-wtdzNWqX64aIMEW6uEgDHzKBWyjHoiQ-8ADsof2rX0FgJBGeBftEcBECMF6qH8_Go29y4epN76desloMBleeHGSZsOJ26djL87ScRoPMm86SQfZ_SHaKdXc6qPNPEAPV6NpnPjZ7fUa83NGWOuHtIRSBUBwRIqA0xmJhGYEKx1EHAJBZyAipkABw6UiEOkZp6rINYaCsjKkB-i0021M_bHUtpWLyuZ6Plfvul5aySl1n3LgjvQ7Mje1tUaXsjHVQpkviUGuK5JdRbKryPEnG-XlzF3-6N9OHJB0gFlUrVTPlW1aabUy-Yus3sv6Z12bZ1nU1drDJQl_MQKEgiDOloVcOKmzTqpeNv_G2rxR2VZ__sHKvMmQU85k8vgkb9hVchnfxfKJfgNkZJLZ</recordid><startdate>2010</startdate><enddate>2010</enddate><creator>Cave, Emma</creator><general>Oxford University Press</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>2010</creationdate><title>SEEN BUT NOT HEARD? CHILDREN IN CLINICAL TRIALS</title><author>Cave, Emma</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c525t-63f0fa402182d473b289e521ae4870493b0985a0a051fa208eb73adce10d35f63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Advisory Committees</topic><topic>Child, Preschool</topic><topic>Children</topic><topic>Clinical trials</topic><topic>Clinical Trials, Phase I as Topic - legislation & jurisprudence</topic><topic>Diseases</topic><topic>Guidelines as Topic</topic><topic>Humans</topic><topic>Informed consent (Medical law)</topic><topic>Informed Consent - legislation & jurisprudence</topic><topic>Internationality</topic><topic>Law and legislation</topic><topic>Patient Rights - legislation & jurisprudence</topic><topic>Pediatrics</topic><topic>Risk Assessment</topic><topic>Treatment</topic><topic>United Kingdom</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Cave, Emma</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Medical law review</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cave, Emma</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>SEEN BUT NOT HEARD? CHILDREN IN CLINICAL TRIALS</atitle><jtitle>Medical law review</jtitle><addtitle>Med Law Rev</addtitle><date>2010</date><risdate>2010</risdate><volume>18</volume><issue>1</issue><spage>1</spage><epage>27</epage><pages>1-27</pages><issn>0967-0742</issn><eissn>1464-3790</eissn><abstract>Although a body of law relating to medical treatment of children exists, the law is relatively undeveloped regarding clinical research. In this article, I consider the implications of the Medicines for Human Use (Clinical Trials) Regulations 2004. I argue that young people's right to self-determination may not be adequately protected. In addition, I explore the implications of a 'direct positive benefit test', which may prove unduly restrictive of some types of paediatric research.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>20129995</pmid><doi>10.1093/medlaw/fwp024</doi><tpages>27</tpages><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 0967-0742 |
ispartof | Medical law review, 2010, Vol.18 (1), p.1-27 |
issn | 0967-0742 1464-3790 |
language | eng |
recordid | cdi_proquest_miscellaneous_733146707 |
source | MEDLINE; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
subjects | Advisory Committees Child, Preschool Children Clinical trials Clinical Trials, Phase I as Topic - legislation & jurisprudence Diseases Guidelines as Topic Humans Informed consent (Medical law) Informed Consent - legislation & jurisprudence Internationality Law and legislation Patient Rights - legislation & jurisprudence Pediatrics Risk Assessment Treatment United Kingdom |
title | SEEN BUT NOT HEARD? CHILDREN IN CLINICAL TRIALS |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-26T06%3A55%3A31IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=SEEN%20BUT%20NOT%20HEARD?%20CHILDREN%20IN%20CLINICAL%20TRIALS&rft.jtitle=Medical%20law%20review&rft.au=Cave,%20Emma&rft.date=2010&rft.volume=18&rft.issue=1&rft.spage=1&rft.epage=27&rft.pages=1-27&rft.issn=0967-0742&rft.eissn=1464-3790&rft_id=info:doi/10.1093/medlaw/fwp024&rft_dat=%3Cproquest_pubme%3E733146707%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=733146707&rft_id=info:pmid/20129995&rft_informt_id=10.3316/agispt.20230921095679&rft_oup_id=10.1093/medlaw/fwp024&rfr_iscdi=true |